NCT02464579

Brief Summary

The objective of this study is to measure the breastfeeding success for all preterm and term newborns in our department of neonatology during the hospital stay and at the age of six months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 3, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

1.2 years

First QC Date

June 3, 2015

Last Update Submit

January 13, 2020

Conditions

Newborn

Keywords

breastfeeding ratepreterm infantneonatal intensive care unit

Outcome Measures

Primary Outcomes (1)

  • Breastfeeding Rate

    A score was established wich combines informations on breastfeeding rate and breastmilk rate into one value. Of special interest was the score at discharge from the neonatologic center.

    6 months

Eligibility Criteria

AgeUp to 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

In-patients of the Department of Neonatology of Cologne.

You may qualify if:

  • Inborn or referred to our Department of Neonatology in the first week of life
  • Informed consent of both parents or legal guardian

You may not qualify if:

  • No informed consent of parent or legal guardian.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neonatology at University Hospital of Cologne

Cologne, 50937, Germany

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Titus Keller, MD

    Neonatology at the University Hospital of Cologne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. Titus Keller

Study Record Dates

First Submitted

June 3, 2015

First Posted

June 8, 2015

Study Start

May 1, 2015

Primary Completion

June 30, 2016

Study Completion

February 1, 2017

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

DE(1)